Section 1Safety1.1 Instructions for the Safe Operation and Use of the Pulse Oximeter

WARNING: EXPLOSION HAZARD Do not use the Pulse Oximeter in a flammable atmosphere where concentrations of flammable products exist.

WARNING: Do not throw batteries in fire as this may cause them to explode.

WARNING: Do not attempt to recharge normal dry-cell batteries as they may leak, cause a fire or explode.

WARNING: Do not use the Pulse Oximeter in an MRI or CT environment.

1.2 Warnings

Do not attempt to service the Pulse Oximeter yourself. Only qualified service personnel should attempt any necessary internal servicing.Prolonged use or depending on the patient's condition may require changing the sensor site periodically. Change sensor site and check skin integrity, circulatory status and correct alignment at least every 2 hours.SpO2 measurements may be adversely affected in the presence of high ambient light. Shield the sensor area if necessary. The following will cause interference to the testing accuracy of the Pulse Oximeter: High-frequency electrosurgical equipment. Placement of the sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line. Patients with hypotension, severe vasoconstriction, severe anaemia or hypothermia. The patient is in cardiac arrest or is in shock. Fingernail polish or false fingernails may cause inaccurate SpO2 readings.

CAUTION: Keep the operating environment free of dust, vibrations, corrosive, or flammable materials, and extremes of temperature and humidity.

CAUTION: Do not operate the unit if it is damp or wet. Avoid using the equipment immediately after moving it from a cold environment to a warm, humid location.

CAUTION: Never use sharp or pointed objects to operate the front-panel switches.

CAUTION: The batteries must be taken out from the battery compart-ment if the device will not be used for more than 12 months.

CAUTION: The device should only be used if the battery cover is closed.

CAUTION: The batteries must be properly disposed of according to local regulation after their use.

CAUTION: The device should be kept away from children & pets to avoid swallowing.

WARNING: If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use of equipment.

WARNING: Do not modify this equipment without authorisation of the manufacturer.

2

# Batch code, Date of manufacturer and Serial No. are printed on the label on the battery cover

Section 2Introduction2 .1 General This chapter provides a general description of the Pulse Oximeter including a brief device description and product features.

1.3 Definitions and Symbols

SN

When the end-user wishes to discard this product, it must be sent to separate collection facilities for recovery and recycling

Temperature limitation

Serial No.# Information of manufacture, including name and address

Caution

Anti-dust & Anti-water class

Note The important information you should know

The information you should know to protect patients and medical staff from possible injuryThe information you should know to protect the equipment from possible damage

Date of manufacture#

Type BF EquipmentSymbol Description

Batch code#

Follow instruction for use

Warning

IPX4

2.2 Brief Device Description The Pulse Oximeter is intended for non-invasive spot-check measurements of functional oxygen saturation of arterial haemoglobin (SpO2). The advanced DSP algorithm^ can minimize the influence of motion and improve measurement accuracy of low perfusion^ .

CAUTION: The device cannot be used in children less than 1 year old as the result may not be accurate.

Measures oxygen saturation (SpO2) and pulse rate (PR). Lightweight & portable. Easy to use. Manually adjust the direction of interface (6 display modes). Dual colour OLED display, simultaneous display for testing value and plethysmograph^ . Low perfusion: 0.2%. Anti-shaking technology. Visual & sound alarm function. Real-time spot-checks. Low battery voltage indicator. Automatic switch off. Standard 2x AAA 1.5V Alkaline batteries will provide more than 20 hours continuous output.

2.3 Product Features

The Pulse Oximeter can be used to measure human oxygen saturation and pulse rate through the finger. The product is suitable for use by individuals and healthcare professionals in multiple situations, including; home, clinical & sporting environments. For example: Pre/post-exercise. Pre/post-operative conditions. Monitoring respiratory conditions.

Section 3Installation, Setup and Operation

Figure 3.1.1 Parts of front & back panel

Table 3.1.1 Part Name and Description

3.1. Description of the Front Panel (as figure 3.1.1)

Item

1

2

Name

3

Description

4

Power Button Turn on/off the machine

Direction Button (M)

Battery Compartment

OLED Panel

Direction change & parameter setting within the menuCompartment for batteries

Displays the SPO2/PR data & Plethysmograph

CAUTION: The fingertip Pulse Oximeter is intended only as an adjunct in patient assessment. It must be used in conjunction with other methods of assessing clinical signs and symptoms.

2.3.1 ^ Defintions^ DSP algorithm: Digital signal processor algorithm.^ Low perfusion: In physiology, perfusion is the process of a body delivering blood to a capillary bed in its biological tissue. Under the condition of low perfusion, the measurement of non-invasive saturation of pulse-blood oxygen can be low.^ Plethysmograph: Instrument for measuring changes in volume within an organ or whole body (usually resulting from fluctuations in the amount of blood or air it contains).

3.2.1 Display ModesThe OLED display can rotate four directions with six different display modes when pressing the direction button (M) as shown below:

3.3 Operation3.3.1 Install batteryRemove cover & install 2 x AAA batteries into the battery cassette in correct polarities and place cover back on.

3.3.2 Turn the Pulse Oximeter OnPress the power button for 2 seconds to turn the Pulse Oximeter on. Open the clamp, then place one finger into rubber hole of the Pulse Oximeter

3.2 DisplayAfter being switched on, the OLED display is as follows:

(it is best to put the finger as far in as possible) with nail surface upward, then release the clamp to shut.

3.3.3. Read data on the display screenThe data may take a few seconds to appear while a reading is obtained. Only your Healthcare Professional can interpret your individual readings.3.3.4. Parameter SettingsIn the parameter settings menu you can set high/ low alarm values for both SpO2 and PR, as well as turning sound on/off. To access the parameter settings hold down the (M) button for one second. There are two types of submenus; Alarm Setup and Sounds Setup. To switch between the setups, ensure the * is next to the word Sounds Setup or Alm Setup, then press (M) for one second to switch between menus, as per figures 3.3.1 and 3.3.2. 3.3.4.1. Sounds SetupHold down the (M) button for one second to bring up the sound menu as per figure 3.3.1. Press (M) quickly to move down the menu. To increase parameter valuesPress (M) quickly to move down the menu until your * signal appears next to the + / - sign. Then hold down (M) for one second until the + sign appears. This will now increase the value of any parameter in this menu. Quickly press (M) to move to the parameter value you wish to change. Once you have reached the parameter value you want to change, hold down (M) for one second and you will see the value increase. Once you've reached your desired level, release the (M) button.

To decrease parameter valuesPress (M) quickly to move down the menu until your * signal appears next to the + / - sign. Then hold down (M) for one second until the - sign appears. This will now decrease the value of any parameter in this menu. Quickly press (M) to move to the parameter value you wish to change. Once you have reached the parameter value you want to change, hold down (M) for one second and you will see the value decrease. Once you've reached your desired level, release the (M) button. 3.3.4.2. Alarm SetupHold down the (M) button for one second to bring up alarm menu as per figure 3.3.2. Press (M) quickly to move down the menu. To turn Alarm or Beep ONPress (M) quickly to move down the menu until your * signal appears next to the word ALM or Beep. Then hold down (M) for one second until the word on appears. To turn Alarm or Beep OFFPress (M) quickly to move down the menu until your * signal appears next to the word ALM or Beep. Then hold down (M) for one second until the word off appears. 3.3.4.3. To Exit Parameter Settings MenuPress (M) quickly to move down the menu until your * signal appears next to the word Exit. Then hold down (M) for one second to exit menu.

Note: 1.The alarm sound has a 1 second delay after an incorrect result is detected.

Figure 3.3.1 Figure 3.3.2

Note: 1. When the battery power is at lowest level, the battery indicator symbol " " appears, indicating replacement of battery is required.2. The plethysmograph can been regarded as correct if the wave is fluctuating constantly.

Section 4Cleaning and Disinfection4.1 Cleaning & Disinfection Switch off the power and take out the batteries before cleaning. Keep the surface of the device clean and free of dust and dirt. Clean the surface (OLED display screen included) of the unit with a soft dry cloth. Disinfect the machine if being used in a clinical setting or by multiple users. To disinfect, use a small amount of 70-75% density medical alcohol on a soft dry cloth to avoid alcohol permeating into the device.

CAUTION: Do not leave any cleaning solution on the surface of the device.

CAUTION: Do not allow any liquid into the product, and do not immerse any parts of the device into any liquids.

CAUTION: Never use an abrasive such as steel wool or metal polish.

3.4.4 Turn the Pulse Oximeter OffPress & hold the power button for 2 seconds. Alternatively the device will automatically shut off after approximately 10-15 seconds.

CAUTION: Do not use strong solvent. e.g acetone.

CAUTION: Avoid pouring liquid on the device while cleaning.

Section 5Troubleshooting and Maintenance5.1 Maintenance Replace the batteries when the battery indicator symbol is low. Clean/disinfect surface of thе Pulse Oximeter before use. Remove the batteries inside the battery cassette if the Pulse Oximeter will not be operated for more than 12 months. Store the product in a place where ambient temperature is -10 to 50℃ and humidity is 15% to 80%. Regularly inspect the device to make sure that no obvious damage exists that will effect the safety and performance of device.

1. Finger is not placed correctly.

2. Finger is trembling or patient is moving.

Oxygen saturation or pulse rate is unstable

1. Retry by placing the finger in the correct position as per instructions.

2. Ensure patient is not moving during measurement.

Problems Possible Reason Resolutions

2. Patient's perfusion is too low to be measured.

1. Finger is not placed correctly.

Oxygen saturation or pulse rate is reading abnormally.

1. Retry by placing the finger in the correct position as per instructions.

2. Retry the measurement, if still reading abnormally, please consult healthcare professional.

5.2 Troubleshooting Table 5.2.1 Troubleshooting

Section 6SpecificationsPulse Oximeter Specifications:Physical CharacteristicsMachineDimensions : 37mm (W)× 74mm (D) × 38mm (H)Weight : approx: 50g(including 2×AAA battery）

Problems Possible Reason Resolutions1. Finger is not placed correctly.

1. Retry by placing the finger in the correct position as per instructions.

Oxygen saturation or pulse rate is abnormal and caused alarm to sound.

2. Patient's SpO2 & PR is abnormal.

2. Please consult healthcare professional.

Pulse Oximeter does not turn on.

1. There maybe inadequate power left in the batteries.

3. The Pulse Oximeter may be damaged.

2. Batteries may have been installed incorrectly.

3. Please contact local customer service center.

2. Please re-install the batteries.

1. Please replace batteries.

1. The product is automatically powered off when no signal is detected longer than approx. 10-15 seconds.

2. Please replace the batteries.

1. This is normal.

The device automatically turns off. 2. There maybe

inadequate power left in the batteries.

Retail package Dimensions:90mm (W) × 120mm (D) × 67mm (H)Gross Weight: 175gClassifications:：Anti-electric Shock Type: Internally powered equipmentAnti-electric Shock Degree: Type BF equipmentEMC: Type B class IMode of operation: Continuous Operation Enclosure Degree of ingress protection: IPX4^ ^ IPX4 means shell of this product can withstand the water from any direction dropping to the surface.

Operating Temperature 5°C to 40°C Relative Humidity 15% to 80% non-condensingAir Pressure 86kPa-106kPa

0-2000 m

Power

2x AAA 1.5V alkaline battery

Less than 30mA(Normal)

Internal

Power Consumption

Operating Altitude

Operation Environmental Condition:

Storage Temperature -10°C to 50°C

Relative Humidity 10% to 80% non-condensingAir Pressure 60kPa-106kPa

0-2000 mOperating Altitude

Transportation and Storage Environmental Condition:

Alarm default value

Parameter

Oxygen Saturation

Pulse Rate

Value

Upper limit: 100 / Lower limit: 90

Upper limit: 130 / Lower limit: 50

Electronics Parameters

Parameter

Oxygen Saturation Display

Pulse Rate Display

ResolutionOxygen Saturation

Pulse Rate

Measure Accuracy Oxygen Saturation

Pulse Rate

35-100%

30-250 BPM

1%

1 BPM

±2 BPM

Probe LED Specification

REDInfra RED

Radiant PowerWave Length660±2 nm905±2 nm

1.8 mW2.0 mW

±2% (70%-100%)unspecified(≤70%)

Value

Should repair be needed within the warranty period, enclose the tear o� section of this warranty card and your proof of purchase receipt. Please ensure all relevant details are completed before sending your unit in for service. Please ensure your contact details are current and include a brief description of the problem you are experiencing together with your proof of purchase.

Include the unit with all product components in your package. This is extremely important, as it will assist our repair technicians in making the correct diagnosis of any problems.

user in regards to ,

Customer Service

J.A.Davey Pty Ltd- Heart Sure Repairs